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-
1
White NJ, Nosten F, Looareesuwan S, Watkins WM, Marsh K, Snow RW, Kokwaro G, Ouma J, Hien TT, Molyneux ME, Taylor TE, Newbold CI, Ruebush TK, Danis M, Greenwood BM, Anderson RM, Olliaro P, 1999. Averting a malaria disaster. Lancet 353 :1965ā1967.
-
2
Trape JF, 2001. The public health impact of chloroquine resistance in Africa. Am J Trop Med Hyg 64 :12ā17.
-
3
Roper C, Pearce R, Bredenkamp B, Gumede J, Drakeley C, Mosha F, Chandramohan D, Sharp B, 2003. Antifolate antimalarial resistance in southeast Africa: a population-based analysis. Lancet 361 :1174ā1181.
-
4
Attaran A, Barnes KI, Curtis C, dāAlessandro U, Fanello CI, Galinski MR, Kokwaro G, Looareesuwan S, Makanga M, Mutabingwa TK, Talisuna A, Francois Trape J, Watkins WM, 2004. WHO, the Global Fund, and medical malpractice in malaria treatment. Lancet 363 :237ā240.
-
5
AFRO, Global AMDP Database. Cited April 24, 2005. Available at http://rbm.who.int/amdp/amdp_afro.htm.
-
6
White N, 2002. The assessment of antimalarial drug efficacy. Trends Parasitol 18 :458ā464.
-
7
Dorsey G, Njama D, Kamya MR, Cattamanchi A, Kyabayinze D, Staedke SG, Gasasira A, Rosenthal PJ, 2002. Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: a longitudinal randomised trial. Lancet 360 :2031ā2038.
-
8
Kremsner PG, Krishna S, 2004. Antimalarial combinations. Lancet 364 :285ā294.
-
9
Staedke SG, Mpimbaza A, Kamya MR, Nzarubara B, Dorsey G, Rosenthal PJ, 2004. Combination therapies for uncomplicated falciparum malaria in Kampala, Uganda: a randomized clinical trial. Lancet 364 :1950ā1957.
-
10
Yeka A, Banek K, Bakyaita N, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Kilian A, Slater M, Reingold A, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, 2005. Artemisinin versus non-artemisinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda. PLoS Med (in press).
-
11
Bakyaita N, Dorsey G, Yeka A, Banek K, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Langi P, Kilian A, Reingold A, Rosenthal PJ, Wabwire-Mangen F, 2005. Sulfadoxine-pyrimethamine plus chloroquine or amodiaquine for uncomplicated falciparum malaria: a randomized, multi-site trial to guide national policy in Uganda. Am J Trop Med Hyg 72 :573ā580.
-
12
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated falciparum Malaria. Cited April 24, 2005. Available at http://www.emro.who.int/rbm/publications/protocolwho.pdf.
-
13
Njama-Meya D, Kamya MR, Dorsey G, 2004. Asymptomatic parasitaemia as a risk factor for symptomatic malaria in a cohort of Ugandan children. Trop Med Int Health 9 :862ā868.
-
14
Talisuna AO, Langi P, Bakyaita N, Egwang T, Mutabingwa TK, Watkins W, Van Marck E, dāAlessandro U, 2002. Intensity of malaria transmission, antimalarial-drug use and resistance in Uganda: what is the relationship between these three factors? Trans R Soc Trop Med Hyg 96 :310ā317.
-
15
Plowe CV, Djimde A, Bouare M, Doumbo O, Wellems TE, 1995. Pyrimethamine and proguanil resistance-conferring mutations in Plasmodium falciparum dihydrofolate reductase: polymerase chain reaction methods for surveillance in Africa. Am J Trop Med Hyg 52 :565ā568.
-
16
Zwetyenga J, Rogier C, Spiegel A, Fontenille D, Trape JF, Mercereau-Puijalon O, 1999. A cohort study of Plasmodium falciparum diversity during the dry season in Ndiop, a Senegalese village with seasonal, mesoendemic malaria. Trans R Soc Trop Med Hyg 93 :375ā380.
-
17
Fenton B, Clark JT, Khan CM, Robinson JV, Walliker D, Ridley R, Scaife JG, McBride JS, 1991. Structural and antigenic polymorphism of the 35- to 48-kilodalton merozoite surface antigen (MSA-2) of the malaria parasite Plasmodium falciparum. Mol Cell Biol 11 :963ā974.
-
18
Dorsey G, Gasasira A, Machekano R, Kamya MR, Staedke SG, Hubbard A, 2004. The impact of age, temperature, and parasite density on treatment outcomes from antimalarial clinical trials in Kampala, Uganda. Am J Trop Med Hyg 71 :531ā536.
-
19
Hien TT, Dolecek C, Mai PP, Dung NT, Truong NT, Thai LH, An DTH, Thanh TT, Stepniewska K, White N, Farrar J, 2004. Dihydroartemisinin-piperaquine against multidrug-resistant Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet 363 :18ā22.
-
20
Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, Cisse M, Cobelens F, Diallo S, Faucher JF, Garner P, Gikunda S, Kremsner PG, Krishna S, Lell B, Loolpapit M, Matsiegui PB, Missinou MA, Mwanza J, Ntoumi F, Olliaro P, Osimbo P, Rezbach P, Some E, Taylor WR, 2002. Amodiaquine-artesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. Lancet 359 :1365ā1372.
-
21
Alloueche A, Bailey W, Barton S, Bwika J, Chimpeni P, Falade CO, Fehintola FA, Horton J, Jaffar S, Kanyok T, Kremsner PG, Kublin JG, Lang T, Missinou MA, Mkandala C, Oduola AM, Premji Z, Robertson L, Sowunmi A, Ward SA, Winstanley PA, 2004. Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet 363 :1843ā1848.
-
22
Rwagacondo CE, Niyitegeka F, Sarushi J, Karema C, Mugisha V, Dujardin JC, van Overmeir C, van den Ende J, dāAlessandro U, 2003. Efficacy of amodiaquine alone and combined with sulfadoxine-pyrimethamine and of sulfadoxine pyrimethamine combined with artesunate. Am J Trop Med Hyg 68 :743ā747.
-
23
Brockman A, Paul REL, Anderson TJC, Hackford I, Phaiphun L, Looareesuwan S, Nosten F, Day KP, 1999. Application of genetic markers to the identification of recrudescent Plasmodium falciparum infections on the northwestern border of Thailand. Am J Trop Med Hyg 60 :14ā21.
-
24
Beck HP, Felger I, Huber W, Steiger S, Smith T, Weiss N, Alonso P, Tanner M, 1997. Analysis of multiple Plasmodium falciparum infections in Tanzanian children during the phase III trial of the malaria vaccine SPf66. J Infect Dis 175 :921ā926.
-
25
Zwetyenga J, Rogier C, Tall A, Fontenille D, Snounou G, Trape JF, Mercereau-Puijalon O, 1998. No influence of age on infection complexity and allelic distribution in Plasmodium falciparum infections in Ndiop, a Senegalese village with seasonal, mesoendemic malaria. Am J Trop Med Hyg 59 :726ā735.
-
26
Happi CT, Gbotosho GO, Sowunmi A, Falade AG, Akinboye DO, Gerena L, Kyle DE, Milhous WK, Wirth DF, Oduola AM, 2004. Molecular analysis of Plasmodium falciparum recrudescent malaria infections in children treated with chloroquine in Nigeria. Am J Trop Med Hyg 70 :20ā26.
-
27
Cattamanchi A, Kyabayinze D, Hubbard A, Rosenthal PJ, Dorsey G, 2003. Distinguishing recrudescence from reinfection in a longitudinal antimalarial drug efficacy study: comparison of results based on genotyping of msp-1, msp-2, and glurp. Am J Trop Med Hyg 68 :133ā139.
-
28
Bendixen M, Masangeni HA, Pedersen BV, Shayo D, Bodker R, 2001. Diversity of Plasmodium falciparum populations and complexity of infections in relation to transmission intensity and host age: a study from the Usambara Mountains, Tanzania. Trans R Soc Trop Med Hyg 95 :143ā148.
-
29
Ranford-Cartwright LC, Taylor J, Umasunthar T, Taylor LH, Babiker HA, Lell B, Schmidt-Ott JR, Lehman LG, Walliker D, Kremsner PG, 1997. Molecular analysis of recrudescent parasites in a Plasmodium falciparum drug efficacy trial in Gabon. Trans R Soc Trop Med Hyg 91 :719ā724.
| Past two years | Past Year | Past 30 Days | |
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| Abstract Views | 20 | 20 | 5 |
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DISTINGUISHING RECRUDESCENCES FROM NEW INFECTIONS IN ANTIMALARIAL CLINICAL TRIALS: MAJOR IMPACT OF INTERPRETATION OF GENOTYPING RESULTS ON ESTIMATES OF DRUG EFFICACY
MADELINE SLATER
MADELINE SLATER
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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MOSES KIGGUNDU
MOSES KIGGUNDU
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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CHRIS DOKOMAJILAR
CHRIS DOKOMAJILAR
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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MOSES R. KAMYA
MOSES R. KAMYA
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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NATHAN BAKYAITA
NATHAN BAKYAITA
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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AMBROSE TALISUNA
AMBROSE TALISUNA
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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PHILIP J. ROSENTHAL
PHILIP J. ROSENTHAL
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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GRANT DORSEY
GRANT DORSEY
Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California; Makerere University Medical School, Kampala, Uganda; Ugandan Ministry of Health, Kampala, Uganda
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The use of molecular genotyping to distinguish recrudescence from new infections has become common in antimalarial clinical trials. However, methods used to interpret genotyping results have not been standardized. We analyzed data from 3,000 patients enrolled in clinical trials at seven sites in Uganda. Late treatment failure requiring genotyping occurred in 51% of the patients. Among samples successfully genotyped, 21% were definitive new infections (no recrudescent strains present on day of failure), 35% were definitive recrudescences (only recrudescent strains present), and 44% were mixed (new and recrudescent strains present). The probability of having a mixed genotyping result increased as transmission intensity increased. At the highest transmission site, the estimated risk of treatment failure increased from 34% to 84% for chloroquine plus sulfadoxine-pyrimethamine, from 18% to 45% for amodiaquine plus sulfadoxine-pyrimethamine, and from 12% to 57% for amodiaquine plus artesunate, depending on whether mixed genotyping results were classified as new infections or recrudescences, respectively. The method used to classify treatment outcomes can have a major impact on estimates of drug efficacy, especially in areas of high transmission intensity.
ProCite
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-
1
White NJ, Nosten F, Looareesuwan S, Watkins WM, Marsh K, Snow RW, Kokwaro G, Ouma J, Hien TT, Molyneux ME, Taylor TE, Newbold CI, Ruebush TK, Danis M, Greenwood BM, Anderson RM, Olliaro P, 1999. Averting a malaria disaster. Lancet 353 :1965ā1967.
-
2
Trape JF, 2001. The public health impact of chloroquine resistance in Africa. Am J Trop Med Hyg 64 :12ā17.
-
3
Roper C, Pearce R, Bredenkamp B, Gumede J, Drakeley C, Mosha F, Chandramohan D, Sharp B, 2003. Antifolate antimalarial resistance in southeast Africa: a population-based analysis. Lancet 361 :1174ā1181.
-
4
Attaran A, Barnes KI, Curtis C, dāAlessandro U, Fanello CI, Galinski MR, Kokwaro G, Looareesuwan S, Makanga M, Mutabingwa TK, Talisuna A, Francois Trape J, Watkins WM, 2004. WHO, the Global Fund, and medical malpractice in malaria treatment. Lancet 363 :237ā240.
-
5
AFRO, Global AMDP Database. Cited April 24, 2005. Available at http://rbm.who.int/amdp/amdp_afro.htm.
-
6
White N, 2002. The assessment of antimalarial drug efficacy. Trends Parasitol 18 :458ā464.
-
7
Dorsey G, Njama D, Kamya MR, Cattamanchi A, Kyabayinze D, Staedke SG, Gasasira A, Rosenthal PJ, 2002. Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: a longitudinal randomised trial. Lancet 360 :2031ā2038.
-
8
Kremsner PG, Krishna S, 2004. Antimalarial combinations. Lancet 364 :285ā294.
-
9
Staedke SG, Mpimbaza A, Kamya MR, Nzarubara B, Dorsey G, Rosenthal PJ, 2004. Combination therapies for uncomplicated falciparum malaria in Kampala, Uganda: a randomized clinical trial. Lancet 364 :1950ā1957.
-
10
Yeka A, Banek K, Bakyaita N, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Kilian A, Slater M, Reingold A, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, 2005. Artemisinin versus non-artemisinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda. PLoS Med (in press).
-
11
Bakyaita N, Dorsey G, Yeka A, Banek K, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Langi P, Kilian A, Reingold A, Rosenthal PJ, Wabwire-Mangen F, 2005. Sulfadoxine-pyrimethamine plus chloroquine or amodiaquine for uncomplicated falciparum malaria: a randomized, multi-site trial to guide national policy in Uganda. Am J Trop Med Hyg 72 :573ā580.
-
12
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated falciparum Malaria. Cited April 24, 2005. Available at http://www.emro.who.int/rbm/publications/protocolwho.pdf.
-
13
Njama-Meya D, Kamya MR, Dorsey G, 2004. Asymptomatic parasitaemia as a risk factor for symptomatic malaria in a cohort of Ugandan children. Trop Med Int Health 9 :862ā868.
-
14
Talisuna AO, Langi P, Bakyaita N, Egwang T, Mutabingwa TK, Watkins W, Van Marck E, dāAlessandro U, 2002. Intensity of malaria transmission, antimalarial-drug use and resistance in Uganda: what is the relationship between these three factors? Trans R Soc Trop Med Hyg 96 :310ā317.
-
15
Plowe CV, Djimde A, Bouare M, Doumbo O, Wellems TE, 1995. Pyrimethamine and proguanil resistance-conferring mutations in Plasmodium falciparum dihydrofolate reductase: polymerase chain reaction methods for surveillance in Africa. Am J Trop Med Hyg 52 :565ā568.
-
16
Zwetyenga J, Rogier C, Spiegel A, Fontenille D, Trape JF, Mercereau-Puijalon O, 1999. A cohort study of Plasmodium falciparum diversity during the dry season in Ndiop, a Senegalese village with seasonal, mesoendemic malaria. Trans R Soc Trop Med Hyg 93 :375ā380.
-
17
Fenton B, Clark JT, Khan CM, Robinson JV, Walliker D, Ridley R, Scaife JG, McBride JS, 1991. Structural and antigenic polymorphism of the 35- to 48-kilodalton merozoite surface antigen (MSA-2) of the malaria parasite Plasmodium falciparum. Mol Cell Biol 11 :963ā974.
-
18
Dorsey G, Gasasira A, Machekano R, Kamya MR, Staedke SG, Hubbard A, 2004. The impact of age, temperature, and parasite density on treatment outcomes from antimalarial clinical trials in Kampala, Uganda. Am J Trop Med Hyg 71 :531ā536.
-
19
Hien TT, Dolecek C, Mai PP, Dung NT, Truong NT, Thai LH, An DTH, Thanh TT, Stepniewska K, White N, Farrar J, 2004. Dihydroartemisinin-piperaquine against multidrug-resistant Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet 363 :18ā22.
-
20
Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, Cisse M, Cobelens F, Diallo S, Faucher JF, Garner P, Gikunda S, Kremsner PG, Krishna S, Lell B, Loolpapit M, Matsiegui PB, Missinou MA, Mwanza J, Ntoumi F, Olliaro P, Osimbo P, Rezbach P, Some E, Taylor WR, 2002. Amodiaquine-artesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. Lancet 359 :1365ā1372.
-
21
Alloueche A, Bailey W, Barton S, Bwika J, Chimpeni P, Falade CO, Fehintola FA, Horton J, Jaffar S, Kanyok T, Kremsner PG, Kublin JG, Lang T, Missinou MA, Mkandala C, Oduola AM, Premji Z, Robertson L, Sowunmi A, Ward SA, Winstanley PA, 2004. Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet 363 :1843ā1848.
-
22
Rwagacondo CE, Niyitegeka F, Sarushi J, Karema C, Mugisha V, Dujardin JC, van Overmeir C, van den Ende J, dāAlessandro U, 2003. Efficacy of amodiaquine alone and combined with sulfadoxine-pyrimethamine and of sulfadoxine pyrimethamine combined with artesunate. Am J Trop Med Hyg 68 :743ā747.
-
23
Brockman A, Paul REL, Anderson TJC, Hackford I, Phaiphun L, Looareesuwan S, Nosten F, Day KP, 1999. Application of genetic markers to the identification of recrudescent Plasmodium falciparum infections on the northwestern border of Thailand. Am J Trop Med Hyg 60 :14ā21.
-
24
Beck HP, Felger I, Huber W, Steiger S, Smith T, Weiss N, Alonso P, Tanner M, 1997. Analysis of multiple Plasmodium falciparum infections in Tanzanian children during the phase III trial of the malaria vaccine SPf66. J Infect Dis 175 :921ā926.
-
25
Zwetyenga J, Rogier C, Tall A, Fontenille D, Snounou G, Trape JF, Mercereau-Puijalon O, 1998. No influence of age on infection complexity and allelic distribution in Plasmodium falciparum infections in Ndiop, a Senegalese village with seasonal, mesoendemic malaria. Am J Trop Med Hyg 59 :726ā735.
-
26
Happi CT, Gbotosho GO, Sowunmi A, Falade AG, Akinboye DO, Gerena L, Kyle DE, Milhous WK, Wirth DF, Oduola AM, 2004. Molecular analysis of Plasmodium falciparum recrudescent malaria infections in children treated with chloroquine in Nigeria. Am J Trop Med Hyg 70 :20ā26.
-
27
Cattamanchi A, Kyabayinze D, Hubbard A, Rosenthal PJ, Dorsey G, 2003. Distinguishing recrudescence from reinfection in a longitudinal antimalarial drug efficacy study: comparison of results based on genotyping of msp-1, msp-2, and glurp. Am J Trop Med Hyg 68 :133ā139.
-
28
Bendixen M, Masangeni HA, Pedersen BV, Shayo D, Bodker R, 2001. Diversity of Plasmodium falciparum populations and complexity of infections in relation to transmission intensity and host age: a study from the Usambara Mountains, Tanzania. Trans R Soc Trop Med Hyg 95 :143ā148.
-
29
Ranford-Cartwright LC, Taylor J, Umasunthar T, Taylor LH, Babiker HA, Lell B, Schmidt-Ott JR, Lehman LG, Walliker D, Kremsner PG, 1997. Molecular analysis of recrudescent parasites in a Plasmodium falciparum drug efficacy trial in Gabon. Trans R Soc Trop Med Hyg 91 :719ā724.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 20 | 20 | 5 |
| Full Text Views | 251 | 87 | 0 |
| PDF Downloads | 46 | 22 | 0 |